Precision stitching in the last several decades has grown more widely in the medical industry because simply, surgeons sew where they can to remove abnormalities or install continuing smaller medical devices. It is a skill honed and mastered early, used virtually in every procedure they are called upon to perform. Originating from basic fabric sewing, it is not that difficult and with practice relatively safe. However, the trend in surgery of implanting medical devices organ removal and bypass type surgical procedures has grown while device size has shrunk.
Some medical device manufacturing companies are now offering suturing systems and devices aimed at delivering the tactile control and precision associated with open procedures to minimally invasive surgery.
Present surgical procedures are challenged for device placement in difficult if not thought to be impossible locations previously and much smaller suturing work spaces. As medical devices grow smaller, components must become stronger to handle the resulting stresses, and surgical techniques and tools must change to meet the challenge of working with yet smaller devices with smaller working spaces. This applies to endoscopic, laparoscopic and minimally invasive surgical procedures as well as more traditional medical procedures.
Some procedures for device implantation have proven inadequate because of weakened attachment and dislodged devices pose ongoing danger. The securing of many medical devices such as stints requires suturing into tissue and onto new and tougher artificial materials, weaves and fabrics. The securing of these potentially dislodged devices is problematic, requiring smaller sewing devices and stronger needles. Smaller devices generally mean weaker needles, and any breakages from weakened sutures or overstressed needles adds to the operation risk. But smaller devices also means less intrusive means of suturing, simplifying the healing, and speeding recovery.
Where the risk is too high, a particular otherwise helpful medical procedure cannot be used. What is needed is: smaller stitching devices, devices which can suture a running stitch or continuous chain of stitching without tearing the tissue or the compromising the thread. What are needed are stitching devices which give the surgeon more precise thread control.
Very Small Tubular Devices
Catheters and other medical devices require very small tubular shapes to enable deployment in the arteries. Many products like Endovascular stent grafts for abdominal and thoracic aortic aneurysms are made of tubular shaped graft material that is ether hand sewn together or precision sewn by machine like the small arm lock stitch machine as taught by Sew Fine™, in 2002 or on sewing devices like the Endovascular deployment machines used to sew deployment sheaths as taught by Sew Fine™, in 1997 and additional equipment provided in 2006. Medical devices used in procedures to support blood vessels, such as Endovascular stent graft, and devices to keep a vessel open, as in coronary stints, it is often the case that the devices are smaller then can be sewn mechanically because the precision cannot meet the dimensional requirements of the work.
The evolving requirements of medical devices and other non-medical devices press the envelope for sewing on smaller parts and yet smaller parts. In attaching endovascular devices, it is often the case that a sewn device requires a smaller more protective stitching needle then what is currently available. Heart tissue weaknesses can be strengthened with suture repairs. Also, with new technologies evolving in the coronary and other endovascular devices, it is necessary to sew closer to a stent or device than is currently possible. What is needed are smaller stitching devices, small enough to work around stent devices, yet strong enough not to break during the procedure and with thread strong enough to last after the procedure has been completed.
What is needed are percutaneous surgeries that can be performed in such a manner as to limit the amount of recovery time required, and leave no visible scars.
One such surgery is called transgastric surgery, or natural orifice translumenal endosurgery, and involves passing flexible surgical tools and a camera in through the patient's mouth to reach the abdominal cavity via an incision made in the stomach lining. Once the operation is over, the surgeon draws any removed tissue out through the patient's mouth and stitches up the hole in the stomach. Surgeons have performed appendectomies through the mouth.
In many ways, transgastric surgery is a natural extension of keyhole surgery, in which slim surgical tools are inserted into the abdomen via small incisions in the skin, avoiding a large cut in the belly. It has now become routine for procedures such as gall bladder removal.
Transgastric surgery promises to go one better. Much of the discomfort and recovery time after conventional surgery, even keyhole surgery, is due to the incisions made in the abdominal wall. However, because transgastric surgeons reach the abdominal cavity through the mouth, there is no need for an incision, so patients should be back up on their feet much faster. Although an incision is still made in the stomach lining, this is relatively painless, because the stomach has fewer nerve fibers that register pain than our skin. The reduced pain also makes it possible for the procedure to be carried without. Consequently, elderly or infirm patients who may otherwise not be fit enough to receive a general anesthetic, could be treated in this manner.
Going in via the esophagus to the stomach may also reduce the risk of post-operative infections with, say, the drug-resistant superbug MRSA, which often lives on the skin. If you don't have skin incisions then you don't get MRSA. And while there is a risk of infecting the abdominal cavity with bacteria from the gastrointestinal tract, animal studies suggest that risk is small because stomach acid is cleansing.
What is needed is surgery that can be made pain-free, convalescence-free and scar-free, whilst reducing the risk of complications and infections.
Stapling is used to close opened tissue in some procedures. However, staples instead of sutures provide a large form body for the body to attack. Also stapling is not a flexible connector often altering the original, natural attachment and the scar tissue is generally more prevalent as a result of stapling. Also, with suture you have the options of using different types, sizes, and strength of suture. What is needed are more suture options. Thus, what is needed are micro sized suturing devices and procedures which can be used in endoscopic, laparoscopic and minimally invasive surgical procedures.
Common Catheterization Procedures
The most common types of interventional catheterization procedures are those performed to: create septal defects, open stenotic valves, open stenotic vessels, close abnormal vessels, or close certain septal defects. Devices and procedures to do these kinds operations are needed, more efficiently and effectively, with less recovery time, smaller chances of infection, and all around cleaner.
Atrial septal defect (ASD) is a hole in the wall, septum, between the heart's two uppermost chambers, the right and left atrium. This hole allows blood to flow in either direction between the left and right atrium. ASDs may cause several problems. First, this creates a condition in which the right side of the heart now contains extra blood, and extra blood also now flows to the lungs. This diversion of blood puts strain on the heart because it has to pump this extra blood to the lungs. In addition, the strain put on the right-sided pumping chamber can lead to a weakening or enlargement of the right side of the heart and eventually heart failure, if left untreated. This enlargement may also cause arrhythmias (irregular heart rhythms) to develop. This extra blood flow to the lungs may damage the arteries to the lungs over time, leading to high blood pressure in these vessels. Also, ASDs in some circumstances can allow blood clots from the body to enter the brain and cause a stroke. Open heart surgery is currently the only option and is done only after all other solutions have failed. What is needed is a small device or procedure to close the hole invasively, so that more drastic, possibly catastrophic, and expensive solutions are not the only option.